title: Rationale and design of the Primary pREvention strategies at the community level to Promote Adherence of treatments to pREvent cardiovascular diseases trial number (CTRI/2012/09/002981).
abstract: BACKGROUND
  Cardiovascular diseases (CVDs) are a leading cause of morbidity and mortality in low-income countries including India. There is a need for effective, low-cost methods to prevent CVDs in rural India. One strategy is to identify and implement interventions at high-risk individuals using community health workers (CHWs). There is a paucity of CHW-based CVD intervention trials from low-income countries.
  
  
  METHODS
  We designed a multicenter, household-level, cluster-randomized trial with 1:1 allocation to intervention and control arms. The CHWs undertook a door-to-door survey and screened 5,699 households in 28 villages from 3 rural regions in India to identify at-risk households. The households were defined as those with ≥1 individual aged ≥35 years and at moderate or high risk for CVD based on the non-laboratory-based National Health and Nutrition Examination Survey score. All at-risk individuals were invited to attend a physician-led village clinic that provided a CVD risk reduction prescription and education about target risk factor levels for CVD control. All households in which at least 1 member at moderate to high risk for CVD had received a risk reduction prescription were eligible for randomization. Households randomized to the CHW-based intervention will receive 1 household visit by a CHW every 2 months, for 12 months. During these visits, CHWs will measure blood pressure, ascertain and reinforce adherence to prescribed therapies, and modify therapy to meet targets. Households randomized to the control arm do not receive CHW visits. At 12 months after randomization, we will evaluate 2 primary outcomes of systolic blood pressure and adherence to antihypertensive drugs and secondary outcomes of INTERHEART risk score, body mass index, and waist-to-hip ratios. At 18 to 24 months after randomization and 6 to 12 months after the last intervention, we will record these outcomes to evaluate sustainability of intervention.
  
  
  RESULTS
  Community health workers screened a total of 5,033 households that included 9,248 individuals and identified 2,571 households with 3,784 at-risk individuals. We randomized 2,438 households (1,219 to intervention and 1,219 to control groups).
  
  
  CONCLUSIONS
  Our large trial of CHWs in rural India will provide important information regarding a promising approach to primary prevention of CVDs.
authors.affiliation: St John's Medical College and Research Institute, Bengaluru, India.
authors.forename: Farah N
authors.initials: FN
authors.lastname: Fathima
authors.forename: Rajnish
authors.initials: R
authors.lastname: Joshi
authors.forename: Twinkle
authors.initials: T
authors.lastname: Agrawal
authors.forename: Shailendra
authors.initials: S
authors.lastname: Hegde
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.forename: Dominic
authors.initials: D
authors.lastname: Misquith
authors.forename: N
authors.initials: N
authors.lastname: Chidambaram
authors.forename: S P
authors.initials: SP
authors.lastname: Kalantri
authors.forename: Clara
authors.initials: C
authors.lastname: Chow
authors.forename: Shofiqul
authors.initials: S
authors.lastname: Islam
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: Rajeev
authors.initials: R
authors.lastname: Gupta
authors.forename: Prem
authors.initials: P
authors.lastname: Pais
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000465:Algorithms; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002985:Clinical Protocols; D003150:Community Health Workers; D006293:Health Promotion; D006801:Humans; D055118:Medication Adherence; D011322:Primary Prevention / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D040242:Risk Reduction Behavior